New Dietary Ingredients (NDI) Draft tough on industry

The Natural Products Association has criticized sweeping new draft guidelines for dietary supplements released by the United States Food and Drug Administration as unnecessary and going beyond Congress’s intent. The draft guidelines raise the safety testing requirements for new dietary ingredients and are intended to help companies comply with a 1994 law regulating ingredients in tablets, powders, liquids and other supplements.

United States-based NPA has held the dietary supplement industry’s first education session about the recently released New Dietary Ingredients (NDI) Draft Guidance by the FDA. The NPA webinar, “NDI Guidance: What You Need to Know,” was attended by nearly 150 manufacturers, trade media and industry stakeholders on July 11.

NPA executive director and CEO John Gay said on July 18: “We are pleased that so many signed up to learn about the impact that the NDI draft guidance may have on the industry. NPA’s education session, the first in the industry, provided an excellent opportunity to hear directly from the FDA about what this guidance means and get additional perspective from industry experts. Several participants expressed concerns about how the draft guidance may affect their business. We believe it is vital that consumers continue to have access to popular, safe dietary supplements.”

Earlier in July, the NPA’s vice president of Scientific and Regulatory Affairs Cara Welch, Ph.D. said the Natural Products Association thanks the FDA for meeting the deadline set by Congress for the release of the NDI guidance. “The draft guidance answers a lot of questions for the industry, but it also raises concerns about its overall impact. It could profoundly affect the ability of Americans to get the supplements they want and need,” she said.

“We believe the draft guidance does not match Congress’s clear intent that products made from ingredients on the market prior to the Dietary Supplement Health and Education Act,should remain on the market. The FDA is asking for far more from the industry to prove that an ingredient was on the market before 1994 than most makers can probably produce. That was not the intent of DSHEA. These requirements will reduce ingredients meeting the established grandfathered status to a regrettably small number.

The draft guidance also addresses a number of situations when a premarket safety notification is required. NDI notifications are required for: components of food marketed before 1994; a change in solvent when processing an ingredient; a change in manufacturing that produces nanoscale particles; and each manufacturer of each supplement containing an NDI. The agency further clarified that synthetic versions of dietary ingredients require an NDI notification, with the exception of synthetic botanical constituents that FDA has declared are not considered dietary ingredients. These situations have the potential to impact dietary supplement manufacturers far and wide.